DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 11/11/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
The application is examined in view of sodium salt of 2-[2-(2,6- dichlorophenyl)aminophenyl]ethanoic acid ( sodium diclofenac) as specific anti-inflammatory agent, claims 1-17, 19 and 21 read on the elected species and are under examination.
Claims 1-21 are pending, claims 1-17, 19 and 21 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/17/2025 is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-17, 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Merat et al. (US20160015609) in view of Yang et al. (US20160256444), Schwarz et al. (US7781429), Schwarz et al. (Schwarz2, US20060241175), Bauer et al. (US4695450) and Bagdi et al. (US7001603).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Merat et al. teaches in W/O emulsion, aqueous phase is gelled by mean of the presence of crosslinked polyelectrolyte (page 1, [0006]). Merat et al. teaches a water-in-oil emulsion comprises (per 100% of its mass):
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The term "crosslinked anionic polyelectrolyte (P)" denotes, in the definition of composition (E1) that is the subject of the present invention, a nonlinear crosslinked
anionic polyelectrolyte, in the form of a three-dimensional network that is insoluble in water, but swellable in water and which leads to the production of a chemical gel (page 2, [0019]).
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The crosslinking agent includes 0.01mol% to 0.5mol% of triallylamine or methylbis(acrylamide) (page 3, [0042]).
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All the disclosure and the claims 1-14 are also incorporated herein by reference. The emulsion composition is considered as liquid (page 12, [0168, 0180]). The W/O emulsion is stable after 3 months of storage at a temperature of 20ºC and is still homogenous ([0182-0183]).
Yang et al. teaches Pharmaceutical compositions and methods for treating or preventing an inflammatory condition in a patient are disclosed (abstract). The composition comprises non-steroidal anti-inflammatory drug such as diclofenac sodium (2-[(2,6-dichlorophenyl)amino]benzeneatic acid, monosodium salt) in one embodiment (claims 46 and 49). The composition is a topical composition in the form of water-in-oil emulsion in one embodiment ([0077, 0079-0080]).
Schwarz et al. teaches topical composition in the form of O/W or W/O emulsion (claim 6) comprising anti-inflammatory drug diclofenac sodium. In one example, the composition comprises 1% of diclofenac sodium in cream wherein diclofenac sodium is dissolved in aqueous phase (column 7, example 3).
Schwarz2 teaches the composition comprises 1-1.5% of diclofenac sodium in emulsion wherein diclofenac sodium is in water phase (page 7, [0080]).
Bauer et al. teaches Doubtless the same would be the case with capsule filling substances, if such emulsions were suitable for encapsulation. However, normal aqueous emulsions, no matter whether they are water-in-oil or oil-in-water emulsions, cannot be encapsulated, because the water contained therein dissolves the gelatin within a short time or at the very least attacks it strongly. It has now been found that anhydrous emulsions consisting of an oil phase (o) and a phase (p) of water-soluble, but anhydrous liquids can be perfectly filled into gelatin capsules. Here and hereinafter "anhydrous" is understood to mean that the hydrophilic phase (p) is in actual fact completely anhydrous or can contain up to 3% water, based on the finished capsule filling. Preferred physiologically unobjectionable, water-soluble, but anhydrous liquids are polyethylene glycols of different molecular weights, particularly those with molecular weights between 300 and 20000, dihydric alcohols, particularly propylene glycol, or trihydric alcohols, particularly glycerol or mixtures thereof (column 1, line 44-65). It is possible to produce propylene glycols or PEG-in-oil emulsions (p/o emulsions) and oil-in-propylene glycol or PEG emulsions (o/p emulsions), as a function of the type of emulsifiers used. A particular advantage compared with conventional filler matrixes is that in the case of the not infrequently encountered PEG incompatibilities, it is possible to use propylene glycol only, whilst omitting PEG. When simultaneously using oil-soluble and water-soluble active agents, it is possible to separately dissolve both medicament types and to administer them in dissolved and readily resorbable form. The hydrophilic active agent is dissolved in the propylene glycol or PEG phase and the lipophilic active agent in the oil phase. Particularly in the case of rectal and vaginal capsules it is important if the medicaments are applied in the dissolved state from the outset, because then resorption can take place more rapidly and completely (column 2, line 20-50).
Bagdi et al. teaches anhydrous emulsion (abstract; column 1, line 45-55). The hydrophilic phase comprises glycol such as propylene glycol and glycerin; the oil phase includes cosmetic acceptable oil (column 2, line 1-30). The compositions of the invention provide a particularly useful base for cleansing and conditioning the Skin. The compositions are applied dry to the Skin, and then water added directly to the treated areas. Upon contact and light rubbing of the wetted composition, the product “blooms', providing a conditioning cream or lotion that can be further rubbed into the skin, and then rinsed off with additional water. After rinse-off, the skin is left remarkably moisturized and Soothed The compositions do not Strip the protective lipid layer, as other cleansers can do, nor do they contain high levels of potentially irritating emulsifiers. Therefore, the compositions can be readily used, even on a daily basis,
by individuals with very dry or sensitive skin, as well as by those with normal skin (column 3, line 30-45).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Merat et al. is that Merat et al. do not expressly teach diclofenac sodium and 1,2-propanediol as dispersed phase. This deficiency in Merat et al. is cured by the teachings of Yang et al., Schwarz et al., Schwarz2, Bauer et al. and Bagdi et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Merat et al., as suggested by Yang et al., Schwarz et al., Schwarz2, Bauer et al. and Bagdi et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to include diclofenac sodium as anti-inflammatory drug because diclofenac sodium is a suitable anti-inflammatory drug in topical composition in the form of emulsion. MPEP 2144.07. Under guidance from Merat et al. teaching anti-inflammatory drug, both Yang et al. and Schwarz et al. teaching diclofenac sodium as anti-inflammatory drug in topical composition in the form of O/W emulsion, it is obvious for one of ordinary skill in the art to include diclofenac sodium as anti-inflammatory drug in the composition of Merat et al. and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to replace propylene glycol (1,2-propanediol) for water as dispersed phase in W/O emulsion to prepare propylene glycol in oil (P/O) emulsion because P/O emulsion is alternative to W/O emulsion. Under guidance from Bauer et al. teaching P/O emulsion particularly useful for encapsulation in gelatin capsule, Bagdi et al. teaching propylene glycol and oil emulsion particularly useful for cleansing and conditioning the Skin. Since it is advantage to do, it is obvious for one of ordinary skill in the art to replace propylene glycol (1,2-propanediol) for water as dispersed phase in W/O emulsion to prepare propylene glycol in oil (P/O) emulsion and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-3, 5-6, 8-9, prior arts teach a composition comprising from 60% to 98% by mass of a gelled phase dispersed in the continued phase comprising: a gelled propylene glycol phase comprising diclofenac sodium as anti-inflammatory drug; a fatty phase comprising oil comprising from 2% to 40% by mass of a fatty phase (A2 ) comprising, per 100% of its mass, from 1.25% to 50% by mass of an emulsifying system (S) comprising one or more emulsifying surfactants selected from alkylpolyglycoside compositions, alkylpolyglycoside and fatty alcohol compositions, polyglycerol esters, alkoxylated polyglycerol esters, polyglycol polyhydroxystearates, polyglycerol polyhydroxystearates, alkoxylated polyglycerol polyhydroxystearates, polyethylene glycol-alkyl glycol copolymers; from 50% to 98.75% by mass of an oi. Since diclofenac sodium is in aqueous phase (hydrophilic phase) as evidenced by Schwarz et al. and Schwarz2, diclofenac sodium is a hydrophilic active agent, under guidance from Bauer et al. teaching, hydrophilic active agent is dissolved in the propylene glycol, diclofenac sodium is in propylene glycol phase. Furthermore, since prior arts teaches the same emulsion with the same oil phase and aqueous phase comprising the same hydrophilic active agent diclofenac sodium; the prior art composition must have the same hydrophilic active agent diclofenac sodium in the propylene glycol phase of the emulsion.
Regarding the composition remains homogenous after storage for at least 3 months in claim1 and the viscosity in claim 21, they are inherency of prior art composition. Since prior art teaches the same o substantially same composition, this same or substantially same composition must have the same properties. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01. II.
Regarding claim 4, the amount of diclofenac sodium in propylene glycol phase in claim 4, prior art teaches from 60% to 98% by mass of an propylene glycol phase (A1) comprising, per 100% of its mass, from 0.05% to 1.65% by mass of a crosslinked anionic polyelectrolyte (P) derived from the polymerization, in the presence of at least one crosslinking agent, of 2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonic acid which is partially or totally salified, with at least one neutral monomer chosen from N,N-dialkylacrylamides. In view of Schwarz et al teaching 1% of diclofenac sodium in the total composition, the amount of diclofenac sodium is about 1/60% to 1/98% = 1.7% to 1%.
Regarding propylene glycol amount in propylene glycol phase in claim 4, the propylene glycol phase comprises propylene glycol, 1-1.7% of anti-inflammatory agent, 0.05% to 1.65% by mass of a crosslinked anionic polyelectrolyte, the propylene glycol amount in propylene glycol phase is (100-1.7-1.65)% to (100-0.05-1)%=96.65% to 98.95% by weight.
Regarding claim 7, Merat et al. teaches a crosslinked anionic polyelectrolyte (P) derived from the polymerization, in the presence of at least one crosslinking agent, of 2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonic acid which is partially or totally salified from 10-90% mol, with at least one neutral monomer chosen from N,N-dialkylacrylamides.
Regarding claim 10 and 16, Merat et al. teaches 1.25% to 50% by mass of an emulsifying system (S) comprising from 15% to 25% of alkyl polyglycoside, 55% to 65% of fatty alcohol and 10% to 30% of polyglycol polyhydroxystearate; and 50% to 98.75% of oil. The amount of alkyl polyglycoside and fatty alcohol is 70-90% vs 10% to 30% of polyglycol polyhydroxystearate, the ratio is more than ¼ or 1.
Regarding claim 11-12 and 14, Merat et al. teaches claim 11 in [0050-0055], Merat et al. further teaches alkyl polyglycoside from 10-50% and fatty alcohol from 90-50% [0069-0070, 0090]).
Regarding claim 13, Merat et al. teaches alkyl polyglycoside as only surfactant, 100%.
Regarding claim 15, Merat et al. teaches claim 15 in [0082].
Regarding claim 17, this is intended use, thus, not limiting.
Regarding claim 19, Merat et al. teaches Fragrance in [0099]).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that impermissible hindsight.
In response to this argument: this is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As discussed in the above 103 rejection, One of ordinary skill in the art would have been motivated to replace propylene glycol (1,2-propanediol) for water as dispersed phase in W/O emulsion to prepare propylene glycol in oil (P/O) emulsion because P/O emulsion is alternative to W/O emulsion. Under guidance from Bauer et al. teaching P/O emulsion particularly useful for encapsulation in gelatin capsule, Bagdi et al. teaching propylene glycol and oil emulsion particularly useful for cleansing and conditioning the Skin. Since it is advantage to do, it is obvious for one of ordinary skill in the art to replace propylene glycol (1,2-propanediol) for water as dispersed phase in W/O emulsion to prepare propylene glycol in oil (P/O) emulsion and produce instant claimed invention with reasonable expectation of success.
Applicants argue that none of reference taches the claimed invention, and all arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the above 103 rejections, Under guidance from Merat et al. teaching anti-inflammatory drug, both Yang et al. and Schwarz et al. teaching diclofenac sodium as anti-inflammatory drug in topical composition in the form of O/W emulsion, it is obvious for one of ordinary skill in the art to include diclofenac sodium as anti-inflammatory drug in the composition of Merat et al. and produce instant claimed invention with reasonable expectation of success. Under guidance from Bauer et al. teaching P/O emulsion particularly useful for encapsulation in gelatin capsule, Bagdi et al. teaching propylene glycol and oil emulsion particularly useful for cleansing and conditioning the Skin; Schwarz et al. O/W emulsion is alternative to W/O emulsion; both O/P emulsion and P/O emulsion will be useful for cleansing and conditioning skin; Since it is advantage to do, it is obvious for one of ordinary skill in the art to replace propylene glycol (1,2-propanediol) for water as dispersed phase in W/O emulsion to prepare propylene glycol in oil (P/O) emulsion and produce instant claimed invention with reasonable expectation of success.
Applicants argue about unexpected results of stability.
In response to this argument: this is not persuasive. Since applicants failed to compare with closest prior art Merat teaching W/O emulsion is stable after 3 months of storage at a temperature of 20ºC and is still homogenous, no unexpected results has been demonstrated, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17, 19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 10-12,14, 16-19 and 21-22 of copending Application No. 17276693 in view of Bauer et al. (US4695450) and Bagdi et al. (US7001603). The reference application teaches each limitation of applicant’s claimed invention except propylene glycol as dispersed phase, in view of Bauer et al. and Bagdi et al. teaching propylene glycol in oil emulsion, and stability and viscosity are considered as inherency of prior art composition, it is obvious to prepare applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-17, 19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17601325 in view of Merat et al. (US20160015609), Yang et al. (US20160256444), Schwarz et al. (US7781429), Schwarz et al. (Schwarz2, US20060241175), Bauer et al. (US4695450) and Bagdi et al. (US7001603). The reference application the claimed emulsion system and surfactants except diclofenac sodium and propylene glycol as dispersed phase, in view of Merat et al., Yang et al., Schwarz et al. and Schwarz et al. teaching diclofenac sodium; Bauer et al. and Bagdi et al. teaching propylene glycol in oil emulsion, and stability and viscosity are considered as inherency of prior art composition, it is obvious to prepare applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-17, 19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-17 of copending Application No. 17633760 in view of Merat et al. (US20160015609), Yang et al. (US20160256444), Schwarz et al. (US7781429) and Schwarz et al. (Schwarz2, US20060241175). The reference application the claimed emulsion system and surfactants except diclofenac sodium, in view of Merat et al., Yang et al., Schwarz et al. and Schwarz et al. teaching diclofenac sodium; and stability and viscosity are considered as inherency of prior art composition, it is obvious to prepare applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to argument:
Applicants argue about the same as 103 rejection.
In response to this argument: this is not persuasive. Since the arguments are not sufficient to overcome the 103 rejection, the same arguments are not sufficient to overcome the double patenting rejections, either.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
Prosecution Insights